Shigella sonnei Fase I serum, 3 mL

Basic Information

• Brand Name: Shigella sonnei Fase I serum, 3 mL
• Primary DI: 05713106664469
• Version / Model: 66446
• Catalog Number: 66446
• Company Name: Ssi Diagnostica A/S
• Labeler DUNS: 305684449
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-13
• Public Version: 4
• Public Version Date: 2023-09-14
• Public Version Status: Update
• Public Device Record Key: 0dd78b3b-7be8-40b0-9d82-5fd98652f0d5
• Distribution End Date: 2021-12-31

Device Description

Rabbit antisera. Ready-To-Use.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GNB	Antisera, All Types, Shigella Spp.	Microbiology	866.3660	2

GMDN Terms

Code	Name	Definition	Implantable	Status
51601	Multiple Shigella species culture isolate antigen IVD, antibody	One or multiple immunoglobulins capable of binding to specific antigenic determinants and intended to be used for the qualitative detection of antigens from one or multiple species of Shigella bacteria isolated by culture from a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05713106664469	GS1